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Quality Assurance / Pre Clinical

GENERAL DESCRIPTION/FUNCTION:

This individual is responsible to provide QA support to the Pre-Clinical Services Unit of our Contract Research/Manufacturing Organization, performing research, process development, analytical method development and non-clinical test article manufacturing/characterization of biopharmaceuticals.

 

As Quality Assurance Associate II/III – Pre-Clinical Services is responsible to:

Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training and other quality systems
Interface and communicate with the Client, Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues
Perform quality review of pre-clinical documentation and certificates of testing
Support external client audits
Perform internal audits of the Pre-Clinical Services department
Implement continuous improvement initiatives
Provide quality oversight of process and analytical method development in an R&D setting for client projects
Provide quality oversight in compliance with GLPs for non-clinical manufacturing and test article characterization for client projects
Interface and communicate with the Client, development teams, technology transfer group and the GMP Unit in meeting project timelines, providing deliverables and resolving issues
Administer the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
Maintain the CAPA Tracking System and track the timely completion and extension of commitments.
Develop, administer and track training of the Pre-Clinical Services group
Assemble and analyze critical quality metrics related to Pre-Clinical Services and report to Senior Management for periodic review
Review and approve release and stability data, certificates of testing, development protocols/batch records/reports, analytical testing protocols/data/reports, analytical method qualification
Conduct review of demonstration batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate
Maintain databases and systems used for tracking various activities
Generate, revise and review Pre-Clinical Services Standard Operating Procedures (SOPs) and other documentation as needed.
Support regulatory (FDA, EMA) and client audits/inspections
Conduct internal and data audits of protocols, raw data, reports, facility records and quality systems
Work independently under general supervision to meet company goals
Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards
Other duties supporting the QA function within the Pre-Clinical Services Department

Skills & Expertise:

Demonstrated experience within the biologic or biopharmaceutical industry performing in a Quality Assurance/Quality Control function within a research or commercial manufacturing company
Familiarity with biological assay and method development (i.e. ELISA, Western Blot, PCR, etc) a plus
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Strong working knowledge of Good Laboratory Practices (GLPs) per 21 CFR 58 and Good Documentation Practices (GDPs). Exposure to Good Manufacturing Practices (GMPs) per 21 CFR Parts 210 and 211, or Quality System Regulations (QSR) per 21 CFR Part 820 or Biological Regulations (21 CFR Part 600s) or EU GMPs
Excellent written and verbal communication skills
Detail oriented with ability to multi-task in a dynamic fast paced environment
Ability to troubleshoot to analyze problems and identify root cause and effective corrective/preventive actions
Familiarity with various office and lab software and ability to quickly learn and navigate new electronic systems
Mature professional able to work in a team setting and independently under minimum supervision
Ability to work outside of standard business hours to meet team/business needs

Measurement of Performance:

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
Timeliness and accuracy in completion of projects and paperwork (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Offers suggestions for correcting problems and for improving operations
Exercises good judgment in dealing with operational problems
Understanding of theory, rationale behind tasks performed
Demonstrated understanding and adherence to policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions

Education & Previous Experience:

B.S. in Biology, Chemistry, Life Sciences or related field, with 5-8 years of relevant experience 
M.S. in Biology, Chemistry, Life Sciences or related field, with 3 – 5 years of relevant experience
Requires broad knowledge and application of the theories and principles utilized to perform
ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable

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